GHENT, BELGIUM--(Marketwire - March 30, 2009) - Ablynx [Euronext Brussels: ABLX], a pioneer in the discovery and development of Nanobodies®, a novel class of antibody-derived therapeutic proteins, announced today the detailed results from the Phase Ib study of its anti- thrombotic ALX-0081. The primary endpoint, demonstrating the complete inhibition of the target protein as measured by a specific biomarker, was reached in December 2008. These positive detailed data support the progression of ALX-0081 into Phase II testing, expected to commence in Q3 2009.
During the period May to December 2008, the study recruited a total of 25 patients with stable angina undergoing an elective percutaneous coronary intervention (PCI) procedure. Total daily doses of ALX- 0081 ranging from 2 to 18 mg were added to a standard anti- thrombotic regimen including aspirin, heparin and Plavix®. The double blind study randomized patients in a 3:1 ratio to either active study drug (ALX-0081) or placebo, resulting in a total of 19 patients receiving ALX-0081 intravenous infusions and six patients receiving placebo. The biological effect of ALX-0081 was determined via a biomarker, indicating the complete inhibition of von Willebrand Factor (vWF) and its mediated effect on platelet aggregation and clotting in coronary arteries.
The study included a single dose and a multiple dose escalation. Single doses were escalated until the required biological effect (complete biomarker inhibition for at least six hours in all ALX- 0081 treated patients) was confirmed. The subsequent multiple dosing was aimed to ensure complete inhibition of the biomarker for at least 24 hours. All patients who received ALX-0081 showed complete inhibition of the biomarker with a duration of 4 to 18 hours in the single dose group and for at least 24 hours in the multiple dose group. In all patients, the pharmacological markers returned to normal 12-36 hours after dosing.
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For more information, please contact:
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Ablynx:
Dr. Edwin Moses
Chairman and CEO
t: +32 (0)9 262 00 07
m: +44 (0)7771 954 193 / +32 (0)473 39 50 68
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Eva-Lotta Allan
Chief Business Officer
t: +32 (0)9 262 00 75
m: +32 (0)475 78 36 21 / +44 (0)7990 570 900
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